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DRI® Assay

For In Vitro Diagnostic Use

10015648 (3 x 18 mL Kit) 0225 (100 mL Kit) 0226 (500 mL Kit)

Intended Use Reagent Preparation and Storage The DRI Barbiturate Assay is intended for the qualitative and semiquantitative determination of The reagents are ready for use. No reagent preparation is required. All assay components, in human urine. when stored at 2-8°C, are stable until the expiration date indicated on the label.

This assay provides only a preliminary analytical test result. A more specific alternative Specimen Collection and Handling chemical method must be used in order to obtain a confirmed analytical result. Gas Collect urine specimens in plastic or glass containers. Testing of fresh urine specimens is chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1,2 Clinical suggested. consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Mandatory Guidelines for Federal Workplace Drug Testing Programs; Final Guidelines recommends that specimens that do not receive an initial test within 7 days of arrival in the Summary and Explanation of the Test laboratory should be placed into secure refrigeration units. Drug abusers may abuse various barbiturates, such as short-acting and long- acting , through oral ingestion or by intravenous and/or intramuscular injection. Samples within a pH range of 3 to 11 are suitable for testing with this assay. Long-term abuse can lead to respiratory depression or, in severe cases, coma. When ingested, a barbiturate is rapidly metabolized and excreted into urine, allowing immunoassays to detect An effort should be made to keep pipetted samples free of gross debris. It is recommended that recent use. highly turbid specimens be centrifuged before analysis. Adulteration of the urine sample may cause erroneous results. If adulteration is suspected, obtain another sample and forward both The DRI® Barbiturate Assay is a homogeneous enzyme immunoassay 3 using ready-to-use liquid specimens to the laboratory for testing. reagents. The assay uses monoclonal antibodies that detect most barbiturates in urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) Handle all urine specimens as if they were potentially infectious. labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of drug from the sample, the G6PDH labeled drug is bound by the specific Assay Procedure antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between Analyzers capable of maintaining a constant temperature, pipetting samples, mixing reagents, drug concentration in urine and the enzyme activity. The enzyme G6PDH activity is determined measuring enzymatic rates at 340 nm and timing the reaction accurately can be used to perform spectrophotometrically at 340 nm by measuring its ability to convert adenine this assay. dinucleotide (NAD) to NADH. Refer to the specific application instructions of each analyzer for chemistry parameters before Reagents performing the assay. Antibody/Substrate Reagent. Contains monoclonal anti-barbiturate antibody, glucose-6-phosphate (G6P), and nicotinamide Quality Control and Calibration adenine dinucleotide (NAD) in Tris buffer with sodium azide as preservative. Qualitative Analysis Enzyme Conjugate Reagent. For qualitative analysis of samples, use the 200 ng/mL calibrator as a cutoff level. The DRI Contains barbiturate labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Multi-Drug Urine Calibrator 2, which contains 200 ng/mL secobarbital, is used as a cutoff sodium azide as preservative. reference for distinguishing “positive” from “negative” samples. In certain applications, 300 ng/mL has been used as a cutoff calibrator. Additional Materials Required (sold separately): Semiquantitative analysis Kit Description For semiquantitative analysis, use all calibrators. 1664 DRI Negative Calibrator, 10 mL 1388 DRI Negative Calibrator, 25 mL Good laboratory practice suggests the use of control specimens to ensure proper assay 1588 DRI Multi-Drug Calibrator 1, 10 mL performance. Use controls near the cutoff calibrator to validate the calibration. Control results 1589 DRI Multi-Drug Calibrator 1, 25 mL must fall within established ranges as determined by your laboratory. If results fall outside 1591 DRI Multi-Drug Calibrator 2, 10 mL of established ranges, assay results are invalid. All quality control requirements should 1592 DRI Multi-Drug Calibrator 2, 25 mL be performed in conformance with local, state and/or federal regulations or accreditation 1594 DRI Multi-Drug Calibrator 3, 10 mL requirements. 1595 DRI Multi-Drug Calibrator 3, 25 mL 1597 DRI Multi-Drug Calibrator 4, 10 mL Results and Expected Values 1598 DRI Multi-Drug Calibrator 4, 25 mL Qualitative results A sample that exhibits a change in absorbance (∆A) value equal to or greater than the ® DOAT-4 MAS DOA Total – Level 4 value obtained with the cutoff calibrator is considered positive. A sample that exhibits a ® DOAT-5 MAS DOA Total – Level 5 change in absorbance (∆A) value lower than the value obtained with the cutoff calibrator is considered negative. Precautions and Warnings This test is for in vitro diagnostic use only. The reagents are harmful if swallowed. Semiquantitative results A rough estimate of drug concentration in the samples can be obtained by running a standard Reagents used in the assay components contain ≤0.09% sodium azide. Avoid contact with skin curve with all calibrators and quantitating samples off the standard curve. and mucous membranes. Flush affected areas with copious amounts of water. Get immediate medical attention for eyes, or if ingested. Sodium azide may react with lead or copper plumbing Limitations to form potentially explosive metal azides. When disposing of such reagents, always flush 1. A positive result from this assay indicates only the presence of barbiturates and does with large volumes of water to prevent azide build-up. Clean exposed metal surfaces with 10% not necessarily correlate to the extent of physiological and psychological effects. sodium hydroxide. 2. A positive result by this assay should be confirmed by another nonimmunological method such as GC, TLC or GC/MS. Do not use the reagents beyond their expiration dates. 3. The test is designed for use with human urine only. 4. It is possible that other substances and/or factors (eg, technical or procedural) not listed in the specificity table may interfere with the test and cause false results.

Typical Performance Characteristics Performance data results obtained on the Hitachi 717 analyzer are shown below.4 The results obtained in your laboratory may differ from these data. Precision The compounds listed in the table below produced a negative result relative to the cutoff The Negative, 200 ng/mL calibrator, 1000 ng/mL calibrator, Control 1 and Control 2 were assayed, calibrator. and the following results were obtained: Compound Concentrations Tested (ng/mL) Qualitative Acetaminophen 1000 Acetylsalicylic acid 1000 Within-run (n=20) Run-to-run (n=17) d-Amphetamine 1000 Calibrator Mean ± SD Mean ± SD % CV % CV Benzoylecgonine 1000 (mA/min) (mA/min) Caffeine 100 0 147 ± 1.4 0.9 147 ± 0.7 0.5 Codeine 1000 200 239 ± 1.2 0.5 235 ± 0.8 0.3 Hydroxphenytoin (HPPH) 500 1000 340 ± 2.1 0.6 332 ± 1.5 0.5 Meperidine 1000 Methadone 1000 Semi-quantitative 1000 Within-run (n=20) Run-to-run (n=17) 1000 Control 500 Mean ± SD Mean ± SD % CV % CV (ng/mL) (ng/mL) Phencyclidine 1000 (DPH) 500 Control 1 157 ± 1.4 0.9 161 ± 2.2 1.4 Propoxyphene 1000 Control 2 264 ± 1.2 0.8 264 ± 3.3 1.3

Sensitivity Sensitivity, defined as the lowest concentration that can be differentiated from the negative urine calibrator with 95% confidence, is 25 ng/mL on the Hitachi 717. References 1. Urine Testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA) Research Accuracy Monograph 73, 1986. One hundred clinical urine specimens were tested with a commercially available EIA assay and 2. Mandatory Guidelines for Federal Workplace Drug Testing Program. National Institute DRI Barbiturate Assay. There was 100% agreement between the two methods. Seventy-eight on Drug Abuse. Federal Register Vol. 53, No 69, pp 11970 (1988). samples were positive and twenty-two were negative by both assays. In addition, all seventy- 3. Rubenstein KE, Schneider RS, and EF Ullman: Homogeneous enzyme immunoassay: eight positive samples were confirmed positive by the GC/MS method. a new immunochemical technique. Biochem Biophys Res Commun 47:846-851 (1972). 4. Data on file at Microgenics, a part of Thermo Fisher Scientific. Specificity Various potentially interfering substances were tested for cross-reactivity with the assay. The compounds listed in the table below produced a result approximately equivalent to the cutoff calibrator. Compound Concentrations Tested (ng/mL) 250 200 200 1500 250 300 Butethal 300 Diallybarbital 600 500 Phenobarbital 600 Secobarbital 200 60 Thiopental 600

Microgenics Corporation Microgenics GmbH 46500 Kato Road Spitalhofstrasse 94 Fremont, CA 94538 USA D-94032 Passau, Germany US Customer and Tel: +49 (0) 851 886 89 0 Technical Support: Fax: +49 (0) 851 886 89 10 1-800-232-3342

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